Balloon vs. stent: new hope for tiny heart arteries?

NCT ID NCT06271590

Recruiting now Disease control Sponsor: Concept Medical Inc. Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This trial tests a special balloon coated with sirolimus (a drug) to treat small arteries in the heart, compared to standard drug-eluting stents. About 1605 people with coronary artery disease will be randomly assigned to one of the two treatments. The goal is to see if the balloon is as safe and effective as stents for keeping these small vessels open.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Sirolimus-coated balloon (MagicTouch)
What this could lead to: If successful, this could offer a stent-free option for treating small heart arteries, potentially reducing long-term complications.
What could go wrong: This is a large trial but still early for this device in small vessels. It may not prove superior or even non-inferior to stents, and risks like vessel injury or need for repeat procedures remain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder coronary artery disorder coronary stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CARDIOVASCULAR DISEASES CORONARY ARTERY DISEASE NATIVE CORONARY ARTERY STENOSIS

Contacts and locations

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Locations

Atlanta VA Medical Center
NOT_YET_RECRUITING

Decatur, Georgia, 30033, United States
Atlanticare Regional Medical Center
RECRUITING

Pomona, New Jersey, 08401, United States
Baylor Scott & White The Heart Hospital - Plano
RECRUITING

Plano, Texas, 75093, United States
Cedars-Sinai Medical Center
NOT_YET_RECRUITING

Los Angeles, California, 90048, United States
Clearwater Cardiovascular and Interventional Consultants
RECRUITING

Clearwater, Florida, 33756, United States
Cleveland Clinic
NOT_YET_RECRUITING

Cleveland, Ohio, 44195, United States
Columbia University/NYP
NOT_YET_RECRUITING

New York, New York, 10032, United States
Dignity Health - Mercy Gilbert Medical Center
NOT_YET_RECRUITING

Gilbert, Arizona, 85297, United States
Emory University Hospital /Emory School of Medice
NOT_YET_RECRUITING

Atlanta, Georgia, 30322, United States
Icahn School of Medicine at Mount Sinai/ Mount Sinai Hospital
RECRUITING

New York, New York, 10029, United States
Loyola University Medical Center
NOT_YET_RECRUITING

Maywood, Illinois, 60153, United States
Montefiore Medical Center
RECRUITING

The Bronx, New York, 10467, United States
NC Heart and Vascular Research, LLC
NOT_YET_RECRUITING

Raleigh, North Carolina, 27607, United States
North Mississippi Medical Center
NOT_YET_RECRUITING

Tupelo, Mississippi, 38801, United States
North Shore University Hospital - Northwell
NOT_YET_RECRUITING

Manhasset, New York, 11030, United States

Contact Email: •••••@•••••
Providence St. Vincent Medical Center
NOT_YET_RECRUITING

Portland, Oregon, 97225, United States
Tallahassee Research Institute
NOT_YET_RECRUITING

Tallahassee, Florida, 32308, United States
Tampa General Hospital / University of South Florida
NOT_YET_RECRUITING

Tampa, Florida, 33606, United States
University Hospitals, Cleveland Medical Center
NOT_YET_RECRUITING

Brooklyn, New York, 11215, United States
University Hospitals, Cleveland Medical Center
NOT_YET_RECRUITING

Cleveland, Ohio, 44106, United States
University of Florida Health Sciences Center-Jacksonville
NOT_YET_RECRUITING

Jacksonville, Florida, 32209, United States
University of Oklahoma Health Science Center
NOT_YET_RECRUITING

Oklahoma City, Oklahoma, 73104, United States
University of Pittsburgh Medical center (UPMC)
NOT_YET_RECRUITING

Pittsburgh, Pennsylvania, 15123, United States
West Virginia University Heart & Vascular Institute
NOT_YET_RECRUITING

Morgantown, West Virginia, 26506, United States

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